EN ISO 21149-2017 en Cosmetics - Microbiology - Enumeration and detection of aerobic mesophilic bacteria.pdf

1、Cosmetics Microbiology Enumeration and detection of aerobic mesophilic bacteriaBS EN ISO 21149:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21149 June 2017 ICS 71.100.70; 07.100.99 Supersedes EN ISO 2114

2、9:2009English Version Cosmetics - Microbiology - Enumeration and detection of aerobic mesophilic bacteria (ISO 21149:2017) Cosmtiques - Microbiologie - Dnombrement et dtection des bactries arobies msophiles (ISO 21149:2017) Kosmetische Mittel - Mikrobiologie - Zhlung und Nachweis von aeroben mesophi

3、len Bakterien (ISO 21149:2017) This European Standard was approved by CEN on 26 April 2017. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date

4、lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation un

5、der the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former

6、 Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION

7、COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 21149:2017 ENational forewordThis British Stand

8、ard is the UK implementation of EN ISO 21149:2017. It is identical to ISO 21149:2017. It supersedes BS EN ISO 21149:2009 , which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CW/217, Cosmetics.A list of organizations represented on this committee can be ob

9、tained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 95716 1ICS 71.100.70; 07.100.99C

10、ompliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 July 2017.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 21149:2017E

11、UROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21149 June 2017 ICS 71.100.70; 07.100.99 Supersedes EN ISO 21149:2009English Version Cosmetics - Microbiology - Enumeration and detection of aerobic mesophilic bacteria (ISO 21149:2017) Cosmtiques - Microbiologie - Dnombrement et dtection des b

12、actries arobies msophiles (ISO 21149:2017) Kosmetische Mittel - Mikrobiologie - Zhlung und Nachweis von aeroben mesophilen Bakterien (ISO 21149:2017) This European Standard was approved by CEN on 26 April 2017. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate

13、 the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Stand

14、ard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the nati

15、onal standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Ser

16、bia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by

17、 any means reserved worldwide for CEN national Members. Ref. No. EN ISO 21149:2017 EBS EN ISO 21149:2017EN ISO 21149:2017 (E) 2 European foreword This document (EN ISO 21149:2017) has been prepared by Technical Committee ISO/TC 217 “Cosmetics” in collaboration with Technical Committee CEN/TC 392 “Co

18、smetics” the secretariat of which is held by AFNOR. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by December 2017, and conflicting national standards shall be withdrawn at the latest by December 2

19、017. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 21149:2009. This document has been prepared under a mandate give

20、n to CEN by the European Commission and the European Free Trade Association. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic,

21、Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. En

22、dorsement notice The text of ISO 21149:2017 has been approved by CEN as EN ISO 21149:2017 without any modification. ISO 21149:2017(E)Foreword v1 Scope . 12 Normative references 13 Terms and definitions . 14 Principle 24.1 General . 24.2 Plate count 24.3 Membrane filtration . 24.4 Detection of bacter

23、ia by enrichment 35 Diluents, neutralizers and culture media . 35.1 General . 35.2 Neutralizing diluents and diluents 35.3 Diluent for the bacterial suspension (tryptone sodium chloride solution) . 45.4 Culture media . 46 Apparatus and glassware 77 Strains of microorganisms . 78 Handling of cosmetic

24、 products and laboratory samples 79 Procedure. 79.1 General recommendation 79.2 Preparation of the initial suspension 79.2.1 General 79.2.2 Water-miscible products. 89.2.3 Water-immiscible products 89.3 Counting methods 89.3.1 Dilutions for counting methods 89.3.2 Plate-count methods 89.4 Enrichment

25、 . 99.4.1 General 99.4.2 Incubation of the sample 910 Counting of colonies (plate counts and membrane filtration methods) 911 Detection of growth (enrichment method) . 912 Expression of results .1012.1 Method of calculation for plate count 1012.2 Interpretation . 1112.3 Examples . 1112.4 Detection a

26、fter enrichment . 1313 Neutralization of the antimicrobial properties of the product .1313.1 General 1313.2 Preparation of inoculum 1413.3 Suitability of counting methods 1413.3.1 Principle . 1413.3.2 Suitability test of the pour-plate method 1413.3.3 Suitability of the surface spread method .1413.3

27、.4 Suitability of the membrane filtration method .1413.4 Suitability of the detection method by enrichment .1513.4.1 Procedure 1513.4.2 Interpretation of results . 1513.5 Interpretation of suitability test results . 1514 Test report 16 ISO 2017 All rights reserved iiiContents PageBS EN ISO 21149:201

28、7ISO 21149:2017(E)Foreword v1 Scope . 12 Normative references 13 Terms and definitions . 14 Principle 24.1 General . 24.2 Plate count 24.3 Membrane filtration . 24.4 Detection of bacteria by enrichment 35 Diluents, neutralizers and culture media . 35.1 General . 35.2 Neutralizing diluents and diluen

29、ts 35.3 Diluent for the bacterial suspension (tryptone sodium chloride solution) . 45.4 Culture media . 46 Apparatus and glassware 77 Strains of microorganisms . 78 Handling of cosmetic products and laboratory samples 79 Procedure. 79.1 General recommendation 79.2 Preparation of the initial suspensi

30、on 79.2.1 General 79.2.2 Water-miscible products. 89.2.3 Water-immiscible products 89.3 Counting methods 89.3.1 Dilutions for counting methods 89.3.2 Plate-count methods 89.4 Enrichment . 99.4.1 General 99.4.2 Incubation of the sample 910 Counting of colonies (plate counts and membrane filtration me

31、thods) 911 Detection of growth (enrichment method) . 912 Expression of results .1012.1 Method of calculation for plate count 1012.2 Interpretation . 1112.3 Examples . 1112.4 Detection after enrichment . 1313 Neutralization of the antimicrobial properties of the product .1313.1 General 1313.2 Prepara

32、tion of inoculum 1413.3 Suitability of counting methods 1413.3.1 Principle . 1413.3.2 Suitability test of the pour-plate method 1413.3.3 Suitability of the surface spread method .1413.3.4 Suitability of the membrane filtration method .1413.4 Suitability of the detection method by enrichment .1513.4.

33、1 Procedure 1513.4.2 Interpretation of results . 1513.5 Interpretation of suitability test results . 1514 Test report 16 ISO 2017 All rights reserved iiiContents PageBS EN ISO 21149:2017ISO 21149:2017(E)Annex A (informative) Other neutralizing diluents .17Annex B (informative) Other diluents 19Annex

34、 C (informative) Other culture media .20Annex D (informative) Neutralizers of antimicrobial activity of preservatives and rinsing liquids 23Bibliography .24iv ISO 2017 All rights reservedBS EN ISO 21149:2017ISO 21149:2017(E)Annex A (informative) Other neutralizing diluents .17Annex B (informative) O

35、ther diluents 19Annex C (informative) Other culture media .20Annex D (informative) Neutralizers of antimicrobial activity of preservatives and rinsing liquids 23Bibliography .24iv ISO 2017 All rights reserved ISO 21149:2017(E)ForewordISO (the International Organization for Standardization) is a worl

36、dwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on

37、that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this d

38、ocument and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Direc

39、tives, Part 2 (see www .iso .org/ directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the deve

40、lopment of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www .iso .org/ patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement. For an explanation on the voluntary n

41、ature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www .iso .org/ iso/ foreword .html.This

42、 document was prepared by Technical Committee ISO/TC 217, Cosmetics.This second edition cancels and replaces the first edition (ISO 21149:2006), of which it constitutes a minor revision with the following changes: in the Scope, “validated” has been changed to “shown to be suitable”; in the Scope, “s

43、ee ISO 29621” has been added and the reference has been added to the Bibliography; in 4.1, “validated” has been changed to “demonstrated”; in 4.3, “validated” has been changed to “described”; in 5.1, “specifications” has been changed to “instructions”; in 9.3.2.1, 9.3.2.2 and 9.3.2.3, “validated” ha

44、s been changed to “described”; in 9.3.2.3, “procedure developed during the validation” has been changed to “suitability test procedure”; in 9.4.1, “validation” has been changed to “suitability test”; in 12.2.1, “validated according to the chosen method” has been changed to “demonstrated to be suitab

45、le for the chosen method”; in 13.3 and 13.4, “validation” has been changed to “suitability”; in 13.3.2, 13.3.3 and 13.3.4, “validation” has been changed to “suitability”; in 13.3.2, 13.3.3 and 13.3.4, “if the validation count is at least 50 % (0,3 log) of the control count” has been changed to “if t

46、he count is at least 50 % of the control”; in 13.4.1, instances of “validation test” have been changed to “suitability test”; ISO 2017 All rights reserved vBS EN ISO 21149:2017ISO 21149:2017(E) in 13.4.2, instances of “validation plate” have been changed to “suitability test plate”; in 13.5, “valida

47、tion results” has been changed to “suitability test results” and “validation plates” has been changed to “suitability test plates”; in Clause 14 f), “validation of the method” has been changed to “demonstration of the suitability”; in A.1, B.1 and C.1, “validated” has been changed to “demonstrated t

48、o be suitable”.vi ISO 2017 All rights reservedBS EN ISO 21149:2017ISO 21149:2017(E) in 13.4.2, instances of “validation plate” have been changed to “suitability test plate”; in 13.5, “validation results” has been changed to “suitability test results” and “validation plates” has been changed to “suit

49、ability test plates”; in Clause 14 f), “validation of the method” has been changed to “demonstration of the suitability”; in A.1, B.1 and C.1, “validated” has been changed to “demonstrated to be suitable”.vi ISO 2017 All rights reserved Cosmetics Microbiology Enumeration and detection of aerobic mesophilic bacteria1 ScopeThis document gives general guidelines for enumeration and detection of aerobic mesophilic bacteria present in cosmetics by counting the colonies on agar medium after aerobic incubation, o